Chronic Disease ManagementPhase 2/3NCT02717403
Effects of Social Networking on Chronic Disease Management in Arthritis
A Phase 2/3 study testing Questionnaires, Facebook and Educational Website in people with Chronic Disease Management and Rheumatoid Arthritis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: The overall goal of this study is to use the principles of chronic disease management to develop and test an online social networking intervention using the FB platform in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease Management, Rheumatoid Arthritis
- What is being tested?
- Questionnaires, Facebook and Educational Website
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2016to 7 Jun 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older (usability test and RCT)
- Staff of the Department of General Internal Medicine (usability test)
- Diagnosis of rheumatoid arthritis by a rheumatologist (RCT)
- Ongoing or prior treatment with traditional disease-modifying anti-rheumatic drugs or biologic agents (RCT)
- Adequate cognitive status as determined by a research coordinator at recruitment. To assess the participant's capacity to take part in the interview, the interviewer will note and comment on the participant's spontaneous speech and capacity to write date at the time of consent. Participants should be oriented to person, place, date, time, and events (RCT)
- Living in the community (not institutionalized, etc. ) (RCT)
Show all 10Show fewer
- Able to communicate in English (RCT)
- Use internet on average at-least once a week (RCT);
- Disease duration 10 years or less (RCT)
- Familiarity with and participation in social media (e.g. Facebook) (usability test and RCT)
Who cannot join
- Participants not willing to complete interviews or survey instruments (usability test and RCT)
- Hospitalized (RCT)
- Patients who do not verbally, written, or electronically consent to participate (usability test and RCT)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase 2 & Phase 3, Effects of Social Networking on Chronic Disease Management in Arthritis
Objectives:
The overall goal of this study is to use the principles of chronic disease management to develop and test an online social networking intervention using the FB platform in a randomized controlled trial. Our specific objectives are as follows:
Read more
Aim 1: To develop and establish an independent closed community in FB for patients with rheumatoid arthritis, providing an educational platform for disease self-management and the potential for engaging in social networking with peers (Phase 2).
Objective 1. To beta test the features and navigation buttons and panels in the newly developed website and FB group.
Objective 2. To evaluate the contents, ease of use and satisfaction with the newly developed website and FB group by patient advocates (consultants to the study) who participate as members of the Facebook community.
Aim 2: To evaluate the efficacy of the FB community intervention combined with an educational website to improve patients' self-management (including knowledge, which is the primary outcome), decision making and patient-reported outcomes compared with the educational website alone (Phase 3). We hypothesize that participation in an online closed community offering evidence-based information combined with peer interaction and support will improve patients' knowledge.
Read the detailed description
Pilot Testing Phase:
Five participants will be recruited to pilot test and give feedback on the control educational website and the FB community. Participants will have access to the educational website and FB, for a period of one week. The main purpose is to test ease of use and satisfaction with both platforms. After 1 week, research staff will call the participant to obtain feedback about the websites. The interview will last approximately 30 minutes and in the case the participant does not finish the interview, the investigators will conduct a follow-up phone interview.
Randomization Phase:
Participants will complete a self response electronic questionnaire at baseline. Participants then randomized into one of two arms: Intervention (FB + Website) and Control (Website alone). The participant will be shown how to access the website and the Facebook page on the internet about rheumatoid arthritis. Patients will be assessed at three and six months after baseline via email self response electronic questionnaires. This phase will recruit 220 participants.
- Conditions
- Chronic Disease Management, Rheumatoid Arthritis
- Being tested
- Questionnaires, Facebook, Educational Website, Phone Interview
- Keywords
- Chronic Disease Management, Rheumatoid Arthritis, Facebook, Social networking, Internet, Questionnaires, Surveys, Phone interview
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Also called Surveys
Participants complete a self response electronic questionnaire at baseline, and at three and six months.
FacebookBehavioural
Also called Social Media
Participant accesses Facebook page regarding rheumatoid arthritis.
Educational WebsiteBehavioural
Participant accesses Educational Website on the internet about rheumatoid arthritis.
Phone InterviewBehavioural
Research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Facebook + Website Group | Experimental | Participants complete a self response electronic questionnaire at baseline. Participant shown how to access the Educational Website and the Facebook page on the internet about rheumatoid arthritis. Patients assessed at three and six months after baseline via email self response electronic questionnaires. Receives: Behavioral: Questionnaires; Behavioral: Facebook; Behavioral: Educational Website |
| Educational Website Group | Experimental | Participants complete a self response electronic questionnaire at baseline. Participant shown how to access the Educational Website on the internet about rheumatoid arthritis. Content includes the following: (i) a learning center; (ii) relevant links to other evidence-based web pages; (iii) news released by major rheumatology and dermatology organizations/societies; and (iv) chronic disease management strategies. Participants assessed at three and six months after baseline via email self response electronic questionnaires. Receives: Behavioral: Questionnaires; Behavioral: Educational Website |
| Pilot Testing Group | Experimental | Participants access the Educational Website and Facebook page about rheumatoid arthritis for a period of one week. After 1 week, research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes. Receives: Behavioral: Facebook; Behavioral: Educational Website; Behavioral: Phone Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)
The Patient Knowledge Questionnaire (PKQ-RA) will measure this outcome.
Measured: 6 months
Secondary outcomes (1)
Control in Health Care Decisions assessed with the Control Preferences Scale (CPS-RA)
The Control Preferences Scale (CPS-RA) used to measure the degree of control an individual wants to assume while making decisions about their health care.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start7 Apr 2016
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Disease ManagementStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Responsible party
- Sponsor
- Investigators
- Angeles M. Lopez-Olivo, MD, PHD, MS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717403
- Sponsor's protocol ID
- 2015-0349
- Other IDs
- 14038089, NCI-2016-00563
- Status last verified
- Jun 2023
- First submitted
- 18 Mar 2016
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez-Olivo MA, Foreman JT, Leung C, Lin HY, Westrich-Robertson T, Hofstetter C, des Bordes JKA, Lyddiatt A, Leong A, Willcockson IU, Peterson SK, Suarez-Almazor ME. A randomized controlled trial evaluating the effects of social networking on chronic disease management in rheumatoid arthritis. Semin Arthritis Rheum. 2022 Oct;56:152072. doi: 10.1016/j.semarthrit.2022.152072. Epub 2022 Jul 16.
PubMed 35872394
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 & Phase 3, Effects of Social Networking on Chronic Disease Management in Arthritis
- ClinicalTrials.gov ID
- NCT02717403
- Acronym / sponsor ID
- 2015-0349
- Conditions
- Chronic Disease Management, Rheumatoid Arthritis
- Keywords
- Chronic Disease Management, Rheumatoid Arthritis, Facebook, Social networking, Internet, Questionnaires, Surveys, Phone interview
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
The overall goal of this study is to use the principles of chronic disease management to develop and test an online social networking intervention using the FB platform in a randomized controlled trial. Our specific objectives are as follows:
Aim 1: To develop and establish an independent closed community in FB for patients with rheumatoid arthritis, providing an educational platform for disease self-management and the potential for engaging in social networking with peers (Phase 2).
Objective 1. To beta test the features and navigation buttons and panels in the newly developed website and FB group.
Objective 2. To evaluate the contents, ease of use and satisfaction with the newly developed website and FB group by patient advocates (consultants to the study) who participate as members of the Facebook community.
Aim 2: To evaluate the efficacy of the FB community intervention combined with an educational website to improve patients' self-management (including knowledge, which is the primary outcome), decision making and patient-reported outcomes compared with the educational website alone (Phase 3). We hypothesize that participation in an online closed community offering evidence-based information combined with peer interaction and support will improve patients' knowledge.
Detailed description
Pilot Testing Phase:
Five participants will be recruited to pilot test and give feedback on the control educational website and the FB community. Participants will have access to the educational website and FB, for a period of one week. The main purpose is to test ease of use and satisfaction with both platforms. After 1 week, research staff will call the participant to obtain feedback about the websites. The interview will last approximately 30 minutes and in the case the participant does not finish the interview, the investigators will conduct a follow-up phone interview.
Randomization Phase:
Participants will complete a self response electronic questionnaire at baseline. Participants then randomized into one of two arms: Intervention (FB + Website) and Control (Website alone). The participant will be shown how to access the website and the Facebook page on the internet about rheumatoid arthritis. Patients will be assessed at three and six months after baseline via email self response electronic questionnaires. This phase will recruit 220 participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Facebook + Website Group | Experimental | Behavioral: Questionnaires, Behavioral: Facebook, Behavioral: Educational WebsiteParticipants complete a self response electronic questionnaire at baseline. Participant shown how to access the Educational Website and the Facebook page on the internet about rheumatoid arthritis. Patients assessed at three and six months after baseline via email self response electronic questionnaires. |
| Educational Website Group | Experimental | Behavioral: Questionnaires, Behavioral: Educational WebsiteParticipants complete a self response electronic questionnaire at baseline. Participant shown how to access the Educational Website on the internet about rheumatoid arthritis. Content includes the following: (i) a learning center; (ii) relevant links to other evidence-based web pages; (iii) news released by major rheumatology and dermatology organizations/societies; and (iv) chronic disease management strategies. Participants assessed at three and six months after baseline via email self response electronic questionnaires. |
| Pilot Testing Group | Experimental | Behavioral: Facebook, Behavioral: Educational Website, Behavioral: Phone InterviewParticipants access the Educational Website and Facebook page about rheumatoid arthritis for a period of one week. After 1 week, research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 years or older (usability test and RCT)
- Staff of the Department of General Internal Medicine (usability test)
- Diagnosis of rheumatoid arthritis by a rheumatologist (RCT)
- Ongoing or prior treatment with traditional disease-modifying anti-rheumatic drugs or biologic agents (RCT)
- Adequate cognitive status as determined by a research coordinator at recruitment. To assess the participant's capacity to take part in the interview, the interviewer will note and comment on the participant's spontaneous speech and capacity to write date at the time of consent. Participants should be oriented to person, place, date, time, and events (RCT)
Key exclusion criteria (3 listed)
- Participants not willing to complete interviews or survey instruments (usability test and RCT)
- Hospitalized (RCT)
- Patients who do not verbally, written, or electronically consent to participate (usability test and RCT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesAlso: SurveysParticipants complete a self response electronic questionnaire at baseline, and at three and six months. | Behavioural | Educational Website Group, Facebook + Website Group |
| FacebookAlso: Social MediaParticipant accesses Facebook page regarding rheumatoid arthritis. | Behavioural | Facebook + Website Group, Pilot Testing Group |
| Educational WebsiteParticipant accesses Educational Website on the internet about rheumatoid arthritis. | Behavioural | Educational Website Group, Facebook + Website Group, Pilot Testing Group |
| Phone InterviewResearch staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes. | Behavioural | Pilot Testing Group |
Primary outcome
Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)
Time frame: 6 months
The Patient Knowledge Questionnaire (PKQ-RA) will measure this outcome.
1 secondary outcome
Control in Health Care Decisions assessed with the Control Preferences Scale (CPS-RA)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 35872394Lopez-Olivo MA, Foreman JT, Leung C, Lin HY, Westrich-Robertson T, Hofstetter C, des Bordes JKA, Lyddiatt A, Leong A, Willcockson IU, Peterson SK, Suarez-Almazor ME. A randomized controlled trial evaluating the effects of social networking on chronic disease management in rheumatoid arthritis. Semin Arthritis Rheum. 2022 Oct;56:152072. doi: 10.1016/j.semarthrit.2022.152072. Epub 2022 Jul 16.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angeles M. Lopez-Olivo, MD, PHD, MS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Questionnaires, Facebook and Educational Website in people with Chronic Disease Management and Rheumatoid Arthritis, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02717403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.